The Politicization of Medicine

An eye-opening result of the COVID pandemic has been the politicization of medicine, evidenced by multiple court judgments.  The Hippocratic Oath has nothing to do with political parties.  Somehow, issues of mask mandates, vaccine mandates and use of certain medications were taken out of the hands of fact-based science and guidance of clinical practitioners and became politicized.

• April 18, 2022, after nearly 15 months of a national mask mandate, the mandate was declared illegal and was reversed by a U.S. district judge as the CDC acted unlawfully and provided no explanation or supporting evidence for the mandate.
• More COVID vaccine transparency for the public was achieved on August 22, 2022, as Pfizer was court ordered to release vaccine data they did not want revealed to the public.
• On October 24, 2022, a New York Supreme Court judge ruled the city’s COVID vaccine mandate to be arbitrary, capricious and unconstitutional.

While these rulings impacted the public, directly impeding critical medical treatment of the public and plausibly prolonging the pandemic, was the FDA’s interference of doctors’ ability to prescribe life-saving medications to treat COVID.

• June 2022, three physicians who prescribed ivermectin to thousands of patients for the treatment of COVID sued the FDA, Department of Health and Human Services, and government employees in their official capacities for overstepping their authority by interfering with their practice of medicine.  

A U.S. District Judge dismissed their lawsuit due to sovereign immunity of the FDA.  The physicians appealed this ruling to the Fifth Circuit Court of Appeals where it was overturned, ruling in favor of the physicians on September 1, 2023.  This blog will summarize the decision.

Background on Ivermectin

Exceptionally safe and inexpensive, winning the Nobel Prize in 2015, ivermectin has a clean safety profile as demonstrated in its 34 years of use in humans and over 3.7 billion doses safely administered world-wide.  It has little if any side effects, is inexpensive, and has been used extensively with such great success, it was named the “Wonder Drug” in 2011, giving it the same status as penicillin and aspirin.  It is also widely used in veterinary medicine for the treatment of worms.  It is a well-studied, well accepted drug in medicine.

The FDA expedited an experimental vaccine with unknown short-term and long-term side effects costing billions.  Yet, the FDA chose not to expedite the use of ivermectin and instead, a concerted effort took place to shut ivermectin down completely and blacklist those who supported it.  Why?

Off-label prescribing is when your physician prescribes a medication the FDA approved to treat a condition different than yours.  For example,

• Gabapentin (Neurontin) is FDA approved for the treatment of seizures but is prescribed off-label to treat nerve pain.
• Fluoxetine (Prozac) is FDA approved for the treatment of major depressive disorder but is prescribed off-label to treat fibromyalgia.

The off-label prescribing of medications is a legal, well-accepted practice in medicine with approximately 20% of all FDA approved medications being prescribed for indications not FDA approved.  However, suddenly there was a major attack on the off-label use of ivermectin to treat COVID and those supporting its use were accused of being of a particular political party, called “quacks,” and were disciplined or threatened if using ivermectin for COVID.  Why?

The War on Ivermectin by Pierre Kory, MD

A book recommended to everyone is The War on Ivermectin, written by Pierre Kory, MD, renowned and well authored critical care and pulmonary medicine physician.  Kory writes, “Ivermectin is a dirty word in the media.  It doesn’t work.  It’s a deadly ‘horse dewormer’.  Prescribe or promote it and you’ll be called a right-wing quack, be banned from social media, or lose your license to practice medicine.  And yet, entire countries wiped out the virus with it, and more than ninety-five studies now show it to be unequivocally effective in preventing and treating COVID-19.  If it didn’t work, why was there a coordinated global campaign to cancel it?  What’s the truth about this decades-old, Nobel Prize-winning medication?”

Why is there such a concerted effort to end the use of ivermectin?  “The evidence base to support ivermectin is now so massive, it’s genuinely incomprehensible that both the media and our so-called health agencies continue to ignore it…Based on a meta-analysis of combined data…the researchers have to date identified forty-two medicines and interventions that lead to improved outcomes in Covid—the vast majority of which have been categorically ignored by the government and media.”

At the top of the list of medications is ivermectin “with ninety-five controlled trials (seventy-eight of which have been published in peer-reviewed medical journals) including over 130,000 patients.  Further, there are numerous published studies of the effects of widespread ivermectin distribution programs from Paraguay, Argentina, Brazil, Mexico, the Philippines, and Peru, all of which reported astonishing success in decreasing hospitalizations and deaths.

In other words, ivermectin is one of the most ‘proven’ medicines in history and also one of the most studied.”

Detailed in Trust the Science an Editorial, a study looked at the 10 largest pharmaceutical companies by revenue in 2020, showing more money is spent by drug makers on selling and marketing than on research and development (R&D) of the new drugs for 7 out of 10 companies.  This study showed advertising and selling exceeded R&D by $36 billion which is 37% more than what is spent on R&D.  This was amid the pandemic when the “focus” was on the development of new treatments and the vaccines, in which safety and effectiveness is questioned.

Further, in 2020, 75% of TV advertisements were for pharmaceutical drugs.  Pharmaceutical companies pay the media an estimated $6 billion a year on advertisements directly targeting consumers.  A study published in JAMA looked at 150 prescription drugs with the highest US sales in 2020, showed drugs with a higher amount of spending on advertisements to consumers were associated with lower added clinical benefit.  As seen with the marketing campaign for the antidepressant Prozac in which the original trials were reanalyzed and restored deeming it both unsafe and ineffective, could it be the financial interest of the pharmaceutical complex and government agencies?

Compared to other interventions pushed by government agencies in the treatment of COVID, ivermectin is the cheapest.  “Nearly every one of them is a patented, exorbitantly costly, ridiculously profitable, Big Pharma pill or injectable.”

• Ivermectin: $1
• Paxlovid: $529
• Molnupiravir: $707
• Monoclonal Antibodies: $2,100
• Remdesivir: $3,120
• Convalescent Plasma: $5,000

Who is the beneficiary here?

Physicians vs FDA

Drs. Robert Apter, Mary Talley Bowden and Paul Marik prescribed ivermectin off-label to over 9,000 patients with COVID with a survival rate of over 99%.  About 18 months into the pandemic, these physicians claim the FDA interfered with their practicing of medicine as it released the following updates to the public:

• A consumer update published by the FDA entitled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19”
• A document published by the FDA entitled “FAQ: COVID-19 and Ivermectin Intended for Animals”
• A post on the FDA website stating, “Q: Should I take ivermectin to prevent or treat COVID-19. A: No.”
• 3 social media posts on Twitter stating the following:
  • “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
  • “You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID.”
  • “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”

These FDA posts quickly disseminated across major news headlines, warning the public not to use the “deadly horse dewormer.”  The following headlines from major news sources summarize this false propagation of information and the media’s direct role in the dissemination of misinformation.

• CNN: What the ivermectin debacle reveals about the hypocrisy of the anti-vaxxer crowd
• CNN: Health officials warn people not to take a drug meant for livestock to ward off or treat Covid-19
• CNN: Arkansas doctor under investigation for prescribing anti-parasitic drug thousands of times for Covid-19 despite FDA warning
• CNN: Right-wing media pushed a deworming drug to treat Covid-19 that the FDA says is unsafe for humans
• ABC: Ivermectin, a deworming drug, should not be used to treat COVID, health officials say
• MSNBC: Despite the evidence, Republicans aren’t quite done with ivermectin
• MSNBC: Misguided people taking ivermectin anti-parasite animal drug
• Washington Post: How those ivermectin conspiracy theories convinced people to buy horse dewormer

Eventually, this misinformation and misrepresentation of ivermectin spread to medical organizations, pharmacy boards and hospitals.  The FDA’s stance was cited across the nation and cited in cases against physicians prescribing it.  The FDA failed to mention ivermectin comes in a human version and has been used safely for decades in billions of doses.  It is common medical practice to prescribe medications off-label, though suddenly off-label use of this medication was not okay.  Why?

Impact on Medical Practice and Reputation

The three physicians allege the FDA’s posts not only interfered with their “ability to exercise professional medical judgment in practicing medicine” but also damaged their reputations.

• Apter was referred to two state medical boards for discipline for prescribing ivermectin
• Pharmacies began to refuse filling ivermectin prescriptions in opposition of the doctors’ orders, directly blocking critical treatment of their patients
• Bowden lost hospital admitting privileges
• Marik, world renowned expert who has authored over 500 peer-reviewed journal articles, 4 critical care textbooks, 80 book chapters, and has been cited in peer-reviewed publications over 43,000 times was forced to resign from his post as chief of pulmonary and critical care in the hospital as well as professor at Eastern Virginia medical school

As a result, they sued the FDA and asked the District Court to

• Declare the FDA’s posts unlawful.
• Declare the FDA “cannot interfere with the practice of medicine.”
• Declare the FDA “cannot issue statements or directives about how or whether health professionals should use ivermectin off-label to treat patients.”
• Direct the FDA “from engaging in such actions.”

FDA Directing Consumers

The FDA claims their posts did not contain medical advice and did not direct consumers.  “The day after FDA issues the first ‘horse’ message, FDA staffers noted that it was ‘the most popular post we’ve ever had on Twitter’ and that they were ‘pleased with the response and the results.’  Staffers also described the Posts as part of a ‘new recommended approach’ that comprised an ‘ambitious effort to counter much of the vaccine [mis]information out there.’  The Posts directed consumers to take specific actions in keeping with the generally applicable principle that FDA had settled on and announced.’”

Just as the CDC exceeded authority and failed to follow regulatory procedures set forth by the federal Administrative Procedure Act (APA) with the mask mandate, the APA in this case allows physicians to bypass the sovereign immunity the FDA seeks to use to support its posts.  The FDA claims they have sovereign immunity in this lawsuit, meaning they are immune from being sued and cannot commit a legal wrong though the physicians can pursue the FDA via the APA.

“FDA is not a physician.”

Ultimately, the Court sided with the physicians, reversing the district court’s dismissal of the lawsuit.  The Judge concluded, “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce or advise. The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to. As such, the Doctors can use the APA to assert their ultra vires claims against the Agencies and the Officials. Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.”

“Perhaps the most insidious of all the problems with mainstream medicine and science is the incestuous relationship it has with the US government.  It is now well established that the pharmaceutical industry is the number one most powerful lobby in Washington…Is it possible that this investment can explain why there is a revolving door between our regulatory agencies and the pharmaceutical industry?”  The mainstream media is complicit in the spreading of misinformation and the villainizing of doctors who rightfully prescribed an established medicine to their patients using their clinical judgment.

This is an important case to follow as it impacts doctors’ practicing of medicine and patient care.  This lawsuit is pending further proceedings.  As seen with the aforementioned court judgments, political ideology has directly interfered with physicians’ ability to freely practice medicine, their decision-making capacity and clinical judgment in doing what is right for their patients.

Will this case ultimately side with the physicians or be dismissed in the end, allowing the revolving door and politicization of medicine to continue?

Have an awesome day!  Dr. D and Drew Chernisky, PA